血液透析治疗患者按照0-1-2月免疫程序接种乙型肝炎疫苗的依从性和免疫原性

Compliance and immunogenicity of 0-1-2-month immunization schedule with hepatitis B vaccine among hemodialysis patients

目的探讨血液透析治疗患者按照0-1-2月免疫程序接种乙型肝炎(乙肝)疫苗(Hepatitis B vaccine,HepB)的依从性和免疫原性。方法采用两种乙肝免疫程序完成率和免疫原性比较的随机对照临床试验,在北京市朝阳区8家医疗机构招募接受血液透析治疗且乙肝表面抗原、乙肝表面抗体(Hepatitis B surface antibody,HBsAb)和乙肝核心抗体均阴性的18-70岁患者,随机分为试验组和对照组,分别按照0-1-2月和0-1-6月免疫程序接种20μg HepB,检测免疫前和免疫后1个月血清HBsAb,比较两组HepB全程接种完成率、HBsAb阳转率和几何平均浓度(GMC)。结果试验组、对照组受试者HepB全程接种完成率分别为94.39%(101/107)、90.83%(99/109)(χ^(2)=1.00,P=0.316);两组全程免疫后HBsAb阳转率分别为70.10%(68/97)、87.76%(86/98)(率差=-17.66%,95%CI下限:-28.84%);GMC分别为60.81mIU/mL、247.08mIU/mL(t=-3.68,P=0.000)。结论血液透析治疗患者HepB 0-1-2月免疫程序的依从性较好,但免疫原性弱于0-1-6月免疫程序。

Objective To explore compliance and immunogenicity of 0-1-2-month immunization schedule with hepatitis B vaccine(HepB)among hemodialysis patients.Methods We conducted a randomized controlled clinical trial of two hepatitis B immunization schedules to compare series completion rates and immunogenicity.We recruited 18-70-year-old patients who were receiving hemodialysis in any of 8 hospitals of Chaoyang district in Beijing and were negative for hepatitis B surface antigen,hepatitis B surface antibody(HBsAb)and hepatitis B core antibody into the trial.Subjects were randomly allocated to either a study group or a control group.The study group received 20μg doses of HepB in a 0-1-2-month schedule;the control group received 20μg doses of HepB in the standard 0-1-6-month schedule.We assessed series completion rates and tested serum samples for HBsAb before and 1 month after vaccination to compare the two groups on full-series completion rates and HBsAb seroconversion and geometric mean concentrations(GMCs).Results Series completion rates were 94.39%(101/107)in the study group and 90.83%(99/109)in the control group(χ^(2)=1.00,P=0.316).After full-series vaccination,HBsAb seroconversion rates were 70.10%(68/97)in the study group and 87.76%(86/98)in the control group(rate difference=-17.66%;lower limit of 95%CI:-28.84%),and GMCs were 60.81 mIU/mL and 247.08mIU/mL(t=-3.68,P=0.000).Conclusions A 0-1-2-month HepB schedule had good compliance among hemodialysis patients but was less immunogenic than a 0-1-6-month schedule.